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Mar 31, 2020
Blueprint Medicines Q1 2020 Earnings Report
Blueprint Medicines reported financial results for Q1 2020 and provided a business update.
Key Takeaways
Blueprint Medicines reported revenues of $6.2 million, including $3.5 million from AYVAKIT sales and $2.7 million in collaboration revenues. The company's cash, cash equivalents, and investments totaled $750.4 million as of March 31, 2020.
Submitted US and EU marketing applications for pralsetinib for RET fusion-positive NSCLC.
AYVAKIT™ (avapritinib) launch in PDGFRA exon 18 mutant GIST underway with reported net product revenue of $3.5M in first partial quarter of launch.
On track to submit NDA to FDA for pralsetinib for previously treated RET mutant MTC in Q2 2020 under FDA’s Real-Time Oncology Review pilot program.
IND for BLU-263 for indolent systemic mastocytosis cleared by FDA.
Blueprint Medicines
Blueprint Medicines
Forward Guidance
Blueprint Medicines expects that its existing cash, cash equivalents and investments, together with anticipated product revenues but excluding any potential option fees, milestone payments or other payments under its collaboration or license agreements, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2022.
Positive Outlook
- Submit an NDA to the FDA for pralsetinib for the treatment of patients with MTC previously treated with an approved multi-kinase inhibitor in the second quarter of 2020 under the FDA’s Oncology Center of Excellence Real-Time Oncology Review pilot program (RTOR program).
- Present updated data from the ARROW trial of pralsetinib in RET-altered cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting.
- Present additional data from Part 1 of the PIONEER trial of avapritinib in indolent SM at the European Academy of Allergy and Clinical Immunology (EAACI) 2020 Congress.
- Present updated data from the EXPLORER trial of avapritinib in advanced SM at the European Hematology Association (EHA) 25th Annual Congress.
- Initiate patient screening for the registration-enabling Part 2 of the PIONEER trial of avapritinib in indolent SM in June 2020.
Challenges Ahead
- Due to the evolving and uncertain global impacts of the COVID-19 pandemic, Blueprint Medicines cannot precisely determine or quantify the impact this pandemic will have on its business, operations (including clinical trials) and financial performance for the remainder of our fiscal year ending December 31, 2020 and beyond.
- For ongoing and planned clinical trials, while the company anticipates and has experienced some temporary delays or disruptions due to the COVID-19 pandemic, Blueprint Medicines is working with any impacted clinical trial sites to ensure study continuity.
- Blueprint Medicines currently has sufficient supply to meet anticipated global commercial and clinical development needs for avapritinib, pralsetinib, fisogatinib and BLU-263 through 2021. However, the COVID-19 pandemic could adversely impact Blueprint Medicines’ suppliers and result in delays or disruptions in the company’s current or future supply chain.
- Blueprint Medicines has shifted commercial and medical affairs field activities across its portfolio toward virtual formats where possible in order to allow the company to continue to serve the needs of healthcare providers, patients and other stakeholders during this critical time.
- As the pandemic evolves, the company anticipates utilizing a mix of in-person and virtual engagement formats, as is locally and regionally appropriate.